Scient'X: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Scient'X” (first 2004, latest 2008), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Scient'X 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | NQP | 2008-04-17 | 349 |
| K062912 | SCIENT'X SPINAL SYSTEM | MNI | 2007-02-05 | 131 |
| K052763 | STELLA CERVICAL PLATE | KWQ | 2005-11-10 | 41 |
| K052367 | SCIENT'X CEMENT RESTRICTOR | JDK | 2005-10-05 | 37 |
| K050348 | CO VERTEBRAL BODY REPLACEMENT | MQP | 2005-05-27 | 105 |
| K051063 | POLYAXIAL HEMISPHERICAL SPINAL SCREWS | MNI | 2005-05-23 | 27 |
| K043001 | MX POLYAXIAL PEDICLE SCREW | MNH | 2004-12-01 | 30 |
| K042964 | MX MONOAXIAL PEDICLE SCREW | MNH | 2004-11-22 | 26 |
| K042317 | CERVICAL PLATE | KWQ | 2004-09-24 | 29 |
| K040747 | ALADYN RIGID SPINE PLATE | MNH | 2004-06-17 | 86 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scient'X.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Scient'X USA, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scient'X?
FDA lists 12 510(k) clearances under the applicant name “Scient'X” (first 2004, latest 2008), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scient'X?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scient'X is 58 days.
Which FDA product codes appear under Scient'X?
The most frequent FDA product codes under this applicant name are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MNI (Orthosis, Spinal Pedicle Fixation, 2).
Next steps
- See all 12 Scient'X clearances with predicates and recalls
- Run predicate analysis for product code MNH, Scient'X's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.